Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Clonidine 2 mcg/ Kg; Drug: Clonidine 3 mcg/ Kg; Drug: Clonidine 1 mcg/Kg

• Registration Number: NCT02769390
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.

Detailed Description

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.

Study Timeline

• Study First Submitted: 2015-04-09
• Study Start: 2015-07
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• CHildren 1 - 10 years old.
• ASA I E II ( American Society of Anesthesiology)
• hypospadias surgery

Exclusion Criteria

• parents refuse
• Infection
• Coagulation disorders
• Allergy to anesthetics
• Abnormalities of the sacral spine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonidine 2 mcg/ Kg	Clonidine 2 mcg/ Kg	IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery
Clonidine 3 mcg/Kg	Clonidine 3 mcg/ Kg	General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery
Clonidine 1 mcg/Kg	Clonidine 1 mcg/Kg	IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery

Primary Outcome Measures

Name	Time	Method
Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption	24 hours after the surgery